Regulatory Affairs CMC Expert

Regulatory Affairs CMC Expert

Galderma

Lausanne, Switzerland

The position is reporting to the Head of Regulatory Affairs CMC.

The RA CMC expert is responsible for preparing and updating the CMC dossier sections and/or technical files for medical device/combination products. Establishes CMC regulatory strategies and data requirements worldwide and prepares CMC/device sections for investigational and commercial products (IMPD, IND, MAA, NDA, ...). Participates to new CMC activities from initial project plan to registration.

Main activities and responsibilities:

  • Develop global CMC regulatory strategies for medical device/combination products to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include device information;
  • Writes/assembles CMC sections and/or technical files of regulatory submissions including clinical trial and variations/supplements as well as registration submission worldwide ensuring alignment with regulations, guidelines, policies and procedures;
  • Manage answers to questions from the Authorities in a timely and effective manner to ensure early approval;
  • Participate to interactions with Competent Authorities;
  • Develop and maintain project plans and schedules for CMC submissions;
  • Evaluate proposed manufacturing changes for global impact and provide regulatory strategies that support change implementation;
  • Review data/documentation provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them;
  • Provide guidance on ICH, FDA and EU CMC guidelines specifically on device/combination product;
  • Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC/device strategies and successfully accomplish regulatory objectives;
  • Represent the Regulatory Affairs CMC function on assigned cross-functional project teams;
  • Responsible for management of the service provider contracted to support a project, if appropriate;
  • Ensures all CMC/device dossiers and relevant regulatory information are stored in the appropriate database according to company’s guideline.

Expected qualifications:

  • BSc, MSc in a scientific discipline or Pharmacist;
  • At least 5 years in CMC Regulatory Affairs;
  • Experience mainly with medical device and combination products (preferred experience with biologics);
  • Experience in interactions with Health Authorities (FDA/EMA) and/or Competent Authorities for Medical Device;
  • Focused on effective delivery of objectives, even when working with tight deadlines;
  • Planning, organizing and time management skills;;
  • Problem solving and analytical skills;
  • Ability to identify opportunities/major issues and to communicate impact;
  • Demonstrated ability to deal with rapid change;
  • Effective verbal and written communication skills in a cross functional environment and with external partners;
  • Fluent in English.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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